510(k) · Cleared
ClearedSynthetic Powdered Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Hongxiang Plastics Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Nov 5, 1999 as substantially equivalent to K960746 (Sunmax Enterprise Shanghai Co., Ltd., 1996) and 1 other predicate after a 78-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Nov 5, 1999
- Review
- 78 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K893822 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK893822 Honyee Vinyl Examination GlovesHonyee Enterprise Co. · 1989
- 2 generations backK960746 Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSunmax Enterprise Shanghai Co., Ltd. · 1996
- 1 generation backK974151 Vinyl Patient Examination Gloves (Powdered)Shanghai Super Gloves Co., Ltd. · 1997
- This deviceK992797 Synthetic Powdered Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co., Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893822 | Honyee Vinyl Examination Gloves | Honyee Enterprise Co. | 1989 | — |
| −2 | K960746 | Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves | Sunmax Enterprise Shanghai Co., Ltd. | 1996 | — |
| −1 | K974151 | Vinyl Patient Examination Gloves (Powdered) | Shanghai Super Gloves Co., Ltd. | 1997 | — |
| 0 (this device) | K992797 | Synthetic Powdered Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960746 | Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSummary page 1…Synthetic Powdered Vinyl Patient Examination Gloves . Predicate Device Information: Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves, K#960746 Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves, K#974151 Classified by FDA’s General and Plastic… | 1996 |
| * | K974151 | Vinyl Patient Examination Gloves (Powdered)Summary page 1…Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves, K#960746 Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves, K#974151 Classified by FDA’s General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glo… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K960746.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992797: Synthetic Powdered Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992797
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026